BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3790553 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-05079
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    December 6, 2013
    Report Date
    May 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE AND OVERSENSING ON ALL CHANNELS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE ISSUE AND SUGGESTED OPTIONS FOR FURTHER EVALUATION. THE DEVICE WAS REPROGRAMMED IN THE INTERIM. THE PATIENT LATER PRESENTED FOR FOLLOW UP AND IT WAS NOTED THAT NOISE WAS NOT REPRODUCIBLE ON THE RV PACE/SENSE LEAD OR SHOCK LEAD WHILE ONLY SLIGHT NOISE WAS NOTED ON THE RA LEAD. A CHEST X-RAY WAS LIKEWISE UNREMARKABLE. TS FURTHER EVALUATED THE ISSUE AND NOTED AN ACUTE INCREASE IN ATRIAL PACING IMPEDANCES AND RV ASYSTOLE GREATER THAN TWO SECONDS. AN INVASIVE INVESTIGATION WAS FURTHER RECOMMENDED; HOWEVER, NO FURTHER INTERVENTION HAS BEEN PERFORMED. AN ADDITIONAL X-RAY WAS REQUESTED AND IT WAS NOTED THAT A FUTURE SYSTEM REVISION IS LIKELY. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268885 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK GUIDANT CRM CLONMEL IRELAND F163

    Patients

    Seq Age Sex Outcome Treatment
    1 F163